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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06624059




Registration number
NCT06624059
Ethics application status
Date submitted
1/10/2024
Date registered
2/10/2024

Titles & IDs
Public title
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status
Secondary ID [1] 0 0
BO43249
Universal Trial Number (UTN)
Trial acronym
HORIZON 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alectinib
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed

Experimental: Cohort B1 - Participants will receive alectinib in combination with platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 5 years.

Experimental: Cohort B2 - Participants will receive alectinib and platinum-based chemotherapy for up to 3 cycles (cycle length = 3 weeks) prior to surgery, and alectinib monotherapy after surgery for up to 5 years after surgery.


Treatment: Drugs: Alectinib
Cohort B1: participants will receive oral alectinib twice daily (BID) for up to 5 years.

Cohort B2: Participants will receive oral alectinib BID for 3 cycles (cycle length = 3 weeks) prior to surgery, and for up to 5 years after surgery.

Treatment: Drugs: Cisplatin
Cohort B1: Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B2: Participants will receive IV cisplatin on Day 1 of each cycle for up to 3 cycles (cycles length = 3 weeks) prior to surgery.

Treatment: Drugs: Carboplatin
Cohort B1: Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B2: Participants will receive IV carboplatin on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.

Treatment: Drugs: Pemetrexed
Cohort B1: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).

Cohort B2: Participants will receive IV pemetrexed on Day 1 of each cycle for up to 3 cycles (cycle length = 3 weeks) prior to surgery.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort B1: Incidence, type, and severity of adverse events (AEs) with onset up to 28 days after the last dose of chemotherapy
Timepoint [1] 0 0
Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
Primary outcome [2] 0 0
Cohort B2: Investigator-assessed pathologic complete response (inv-pCR)
Timepoint [2] 0 0
At the time of surgical resection (approximately weeks 14-17)
Secondary outcome [1] 0 0
Cohort B1: Investigator-assessed disease-free survival (DFS)
Timepoint [1] 0 0
From initiation of study treatment to the first documented recurrence of disease or new primary NSCLC or death from any cause, whichever occurs first (up to approximately 5 years)
Secondary outcome [2] 0 0
Cohort B1: Overall survival (OS)
Timepoint [2] 0 0
From initiation of study treatment to death from any cause (up to approximately 8 years)
Secondary outcome [3] 0 0
Cohort B1: Incidence, type, and severity of AEs with onset up to 28 days after the last dose of study treatment
Timepoint [3] 0 0
From first dose to up to approximately 5 years
Secondary outcome [4] 0 0
Cohort B1: Time to first onset of selected AEs
Timepoint [4] 0 0
From first dose to up to approximately 5 years
Secondary outcome [5] 0 0
Cohort B1: Change from baseline in target safety parameters
Timepoint [5] 0 0
From first dose to up to approximately 5 years
Secondary outcome [6] 0 0
Cohort B2: Investigator-assessed major pathological response (inv-MPR)
Timepoint [6] 0 0
At the time of surgical resection (approximately weeks 14-17)
Secondary outcome [7] 0 0
Cohort B2: Pathologic complete response (pCR) by independent review
Timepoint [7] 0 0
At the time of surgical resection (approximately weeks 14-17)
Secondary outcome [8] 0 0
Cohort B2: Major pathologic response (MPR) by independent review
Timepoint [8] 0 0
At the time of surgical resection (approximately weeks 14-17)
Secondary outcome [9] 0 0
Cohort B2: Investigator-assessed overall response rate (ORR)
Timepoint [9] 0 0
Up to approximately Week 17
Secondary outcome [10] 0 0
Cohort B2: Investigator-assessed event-free survival (EFS)
Timepoint [10] 0 0
From first treatment to the first documented disease progression that prevents surgery, local or distant disease recurrence, or death from any cause (up to approximately 5 years)
Secondary outcome [11] 0 0
Cohort B2: Overall Survival (OS)
Timepoint [11] 0 0
From initiation of study treatment to death from any cause (up to approximately 8 years)
Secondary outcome [12] 0 0
Cohort B2: Incidence, severity, and type of AEs
Timepoint [12] 0 0
From first dose up to approximately 5 years
Secondary outcome [13] 0 0
Cohort B2: Change from baseline in target safety parameters
Timepoint [13] 0 0
From first dose to up to approximately 5 years
Secondary outcome [14] 0 0
Cohort B2: Frequency of surgery completion, defined as participants who have successfully completed surgery without treatment-related delays (> 60 days) from the last dose of neoadjuvant treatment
Timepoint [14] 0 0
At the time of surgical resection (approximately weeks 14-17)
Secondary outcome [15] 0 0
Cohort B2: Length of treatment-related surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations
Timepoint [15] 0 0
Approximately weeks 14-24

Eligibility
Key inclusion criteria
Inclusion Criteria Cohort B1:

* Complete resection of the primary NSCLC with negative margins
* Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1

Inclusion Criteria Cohort B2:

* Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
* Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology

Inclusion Criteria Cohorts B1 and B2:

* Documented ALK fusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Cohort B1:

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohort B2:

* NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
* Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
* Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohorts B1 and B2:

* Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2033
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leornards
Recruitment hospital [2] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leornards
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO43249 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06624059